Case Study / Scenario

Overview

Request a New Labeler Code

Elements of Scenario

• Manufacturer
• Labeler Code not yet provided by FDA

XML for this type of Registration/Listing

[Text in red must be replaced with your own unique information]

<?xml version="1.0" encoding="UTF-8"?>
<?xml-stylesheet href="http://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 http://www.accessdata.fda.gov/spl/schema/spl.xsd">
<id root="537f14b1-b841-4fca-a2d1-20624a1c1ed9"/>
<code code="51726-8" codeSystem="2.16.840.1.113883.6.1" displayName="NDC LABELER CODE REQUEST"/>
<effectiveTime value="20080909"/>
<setId root="537f14b1-b841-4fca-a2d1-20624a1c1ed9"/>
<versionNumber value="1"/>
<author>
<time/>
<assignedEntity>
<representedOrganization>
<id extension="999999999" root="1.3.6.1.4.1.519.1"/>
<id extension="" root="2.16.840.1.113883.6.69"/>
<name>Acme Drugs Devices and More</name>
<contactParty>
<addr>
<streetAddressLine>100 Main Street</streetAddressLine>
<city>Portland</city>
<state>Michigan</state>
<postalCode>48100</postalCode>
<country>USA</country>
</addr>
<telecom value="tel:+1-999-555-1212"/>
<telecom value="[[mailto:info@addm.co.us"/|mailto:]][[mailto:info@addm.co.us"/|info@addm.co.us]][[mailto:info@addm.co.us"/|"/]]>
<contactPerson>
<name>William E Kaiote</name>
</contactPerson>
</contactParty>
</representedOrganization>
</assignedEntity>
</author>
<component>
<nonXMLBody>
<text/>
</nonXMLBody>
</component>
</document>

See also

Register an existing Labeler Code
Response from FDA on Obtaining New Labeler Code

References

Xforms PDF